MAUDE Adverse Event Report: INTERVASCULAR SAS INTERGARD WOVEN AORTIC ARCH GRAFT; VASCULAR POLYESTER GRAFT

Model Number	HEWAA2610080810/1
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/17/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the device history records indicated that the graft was processed and inspected according to procedures and no anomaly was found.The investigation is pending the product return.No conclusion can be drawn at the time of this report.
Event or Problem Description
It was reported that the product packaging components presented stains.
Additional Manufacturer Narrative
The inspection of the returned product revealed stains on the outer and inner tyvek lid and also on the patient record labels.The nature of stains is suspected to be of glycerol nature (raw material in the manufacturing process).The product, as it was received, does not conform to its specification.However, this product is involved in a recall initiated following a previous similar complaint.The performed investigation concluded that the product might have been exposed to inadequate storage conditions at the (b)(4) distributor warehouse (mfr report number 1640201-2015-00024).

• Brand Name: INTERGARD WOVEN AORTIC ARCH GRAFT
• Common Device Name: VASCULAR POLYESTER GRAFT
• Manufacturer (Section D): INTERVASCULAR SAS; zi athelia 1; la ciotat cedex, 13705 ; FR 13705
• MDR Report Key: 5586412
• Report Number: 1640201-2016-00012
• Device Sequence Number: 174855
• Product Code: DSY
• UDI-Device Identifier: 00384401010746
• UDI-Public: 00384401010746
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K013651
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Expiration Date: 08/31/2019
• Device Model Number: HEWAA2610080810/1
• Device Catalogue Number: HEWAA2610080810/1
• Device Lot Number: 14J25
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/23/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/19/2016
• Supplement Report FDA Received Date: 06/24/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1